FDA 510(k)

DISCOVERY NM 750B

K-Number: K102231 · 2010-11-03

ApplicantGe Medical Systems Israel, Functional Imaging

Decision Date2010-11-03

Product CodeIYX

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DISCOVERY NM 750B is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Israel, Functional Imaging. It received FDA 510(k) clearance on 2010-11-03 under 510(k) number K102231. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISCOVERY NM 750B?

DISCOVERY NM 750B is a medical device that received FDA 510(k) clearance on 2010-11-03. The listed applicant is Ge Medical Systems Israel, Functional Imaging. The 510(k) number is K102231.

When did DISCOVERY NM 750B receive FDA 510(k) clearance?

DISCOVERY NM 750B received FDA 510(k) clearance on 2010-11-03, under 510(k) number K102231.

Who is the listed applicant for DISCOVERY NM 750B?

The FDA 510(k) record lists Ge Medical Systems Israel, Functional Imaging as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISCOVERY NM 750B?

The FDA product code for DISCOVERY NM 750B is IYX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.